Clinical Trials Logo

Clinical Trial Summary

Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.


Clinical Trial Description

The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation.

Two A and B study groups of paraplegic subjects will be built-up in a randomized way. Under standardized conditions, the A study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. Under the same conditions but without the developed device, the B study group subject will have an usual behavior.

The analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00429013
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Terminated
Phase Phase 2
Start date September 2006
Completion date March 2009

See also
  Status Clinical Trial Phase
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A
Completed NCT00838838 - Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis N/A
Completed NCT05563402 - "Evaluation of Usability and Safety of the Self-balancing Walking System Atalante in Patients With Multiple Sclerosis" N/A
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Enrolling by invitation NCT02602639 - Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury N/A
Completed NCT00385918 - Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) N/A
Recruiting NCT04397250 - High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury N/A
Terminated NCT02412046 - Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics N/A
Completed NCT06169969 - Effect Of Magnetic Therapy In Bladder Dysfunction And Quality Of Life In Paraplegic Patients N/A
Recruiting NCT01474148 - A Neuroprosthesis for Seated Posture and Balance N/A
Terminated NCT03114345 - Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient N/A
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT01739023 - Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI Phase 1
Terminated NCT01498991 - Spinal Cord Injury Leg Rehabilitation Phase 1/Phase 2
Recruiting NCT06071949 - Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Recruiting NCT06072001 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis Phase 3
Completed NCT04215081 - ExoAtlet II For SCI Patients N/A
Completed NCT04110561 - Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis N/A
Completed NCT00270855 - Exercise to Reduce Obesity in Spinal Cord Injury N/A
Active, not recruiting NCT00059553 - Retraining Walking After Spinal Cord Injury Phase 2/Phase 3